BACKGROUND: The aim of this trial was to evaluate the induction and recovery characteristics of microemulsion propofol (Aquafol; Daewon Pharmaceutical Co., Ltd., Seoul, Korea). Pharmacokinetics, pharmacodynamics, and safety profile were investigated. Lipid emulsion propofol (Diprivan; AstraZeneca, London, United Kingdom) was used as a comparator. METHODS:Thirty-one healthy volunteers aged 20-79 yr were given an intravenous bolus of propofol 2 mg/kg, followed by variable rate infusion for 60 min. Each volunteer was studied twice with different formulations at an interval of 1 week. Arterial concentrations of propofol were measured, and Bispectral Index was used as a surrogate measure of propofol effect. The induction and recovery characteristics including bioequivalence were evaluated by noncompartmental analysis. The pharmacokinetics and pharmacodynamics were investigated using a population approach with mixed effects modeling. The rate, severity, and causal relation of adverse events were analyzed. RESULTS: Both formulations were bioequivalent. The observed time to peak effect after a bolus of both formulations was 1.5 min. Plasma concentration of propofol at loss of consciousness, time to loss of consciousness after a bolus, and time to recovery of consciousness after discontinuation of infusion did not show significant differences. The population pharmacokinetics and pharmacodynamics revealed a variety of differences between two formulations. Aquafol showed similar safety profile to Diprivan. CONCLUSIONS: The efficacy and safety of Aquafol were not different from those of Diprivan within the dose range in this study.
RCT Entities:
BACKGROUND: The aim of this trial was to evaluate the induction and recovery characteristics of microemulsion propofol (Aquafol; Daewon Pharmaceutical Co., Ltd., Seoul, Korea). Pharmacokinetics, pharmacodynamics, and safety profile were investigated. Lipid emulsion propofol (Diprivan; AstraZeneca, London, United Kingdom) was used as a comparator. METHODS: Thirty-one healthy volunteers aged 20-79 yr were given an intravenous bolus of propofol 2 mg/kg, followed by variable rate infusion for 60 min. Each volunteer was studied twice with different formulations at an interval of 1 week. Arterial concentrations of propofol were measured, and Bispectral Index was used as a surrogate measure of propofol effect. The induction and recovery characteristics including bioequivalence were evaluated by noncompartmental analysis. The pharmacokinetics and pharmacodynamics were investigated using a population approach with mixed effects modeling. The rate, severity, and causal relation of adverse events were analyzed. RESULTS: Both formulations were bioequivalent. The observed time to peak effect after a bolus of both formulations was 1.5 min. Plasma concentration of propofol at loss of consciousness, time to loss of consciousness after a bolus, and time to recovery of consciousness after discontinuation of infusion did not show significant differences. The population pharmacokinetics and pharmacodynamics revealed a variety of differences between two formulations. Aquafol showed similar safety profile to Diprivan. CONCLUSIONS: The efficacy and safety of Aquafol were not different from those of Diprivan within the dose range in this study.
Authors: Alireza Hassani Najafabadi; Saman Azodi-Deilami; Majid Abdouss; Hamid Payravand; Sina Farzaneh Journal: J Mater Sci Mater Med Date: 2015-03-06 Impact factor: 3.896
Authors: Timothy E Morey; Jerome H Modell; Jorge E Garcia; Michael Bewernitz; Hartmut Derendorf; Manoj Varshney; Nikolaus Gravenstein; Dinesh O Shah; Donn M Dennis Journal: Biopharm Drug Dispos Date: 2010-07 Impact factor: 1.627
Authors: Hyun-Sik Kim; Kwang Rae Cho; Jeong Han Lee; Young Hwan Kim; Se Hun Lim; Kun Moo Lee; Soon Ho Cheong; Young Jae Kim; Chee-Mahn Shin; Jin-Young Lee Journal: Korean J Anesthesiol Date: 2010-11-25